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Ventilation Beyond Limits
fabian Therapy evolution
and Auxiliary Systems
Instructions for Use, Software Version 5.1.x
Warning
Carefully read the instructions of use
before using the ventilator to
familiarise yourself with the function of
the equipment
fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
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Summary of Contents for ACUTRONIC fabian Therapy evolution
- Page 1 Auxiliary Systems Instructions for Use, Software Version 5.1.x Warning Carefully read the instructions of use before using the ventilator to familiarise yourself with the function of the equipment fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 2 DISCLAIMER ACUTRONIC Medical Systems assumes no responsibility for the use or reliability of its software on equipment that is not furnished by ACUTRONIC Medical Systems. ACUTRONIC Medical Systems makes no warranty of any kind with regard to software applications that are created by the user.
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Page 3: Table Of Contents
Connect the power supply ....................28 5.1.2 Connect the gas supply ......................28 5.1.3 Connect nCPAP tubing ......................29 5.1.4 Triggering in DUOPAP mode with flow sensor (optional) ............. 29 System start-up......................30 fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 4 12 Accessories and options ....................67 12.1 Accessories List......................67 12.2 SpO 2 module ......................69 12.2.1 Setting up the Masimo sensor ....................69 12.2.2 Sensitivity mode ........................70 fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 5 18 Electromagnetic compatibility statement............... 94 18.1 Device with SN from AT-04000 .................. 95 18.2 Device with SN till AT-04000..................99 19 Appendix A: Glossary ....................103 20 Appendix B: Index ......................105 fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 6: Introduction
Notes provide additional information to clarify an explanation or instruction. 1.3 Applicable product versions This Instructions for Use is applicable for fabian Therapy evolution devices running software version 5.1.x, where (x) can be any number. fabian Therapy evolution | SW 5.1.x... -
Page 7: Symbols
Potential equalisation connection. Flammability Fire hazard warning. Flow sensor connection Sensor Flow sensor connection. External power supply input Fragile, Handle with care. High Frequency interference warning. Keep away from heat. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 8 Type B applied part Unplug power before opening housing. Video Output USB connection. Warning regarding operation in explosive areas. Do not use if package is damaged Expiration Date Storage Temperature fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 9 Introduction Symbol Description Humidity Limitation Medical Device fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 10: Warnings Cautions And Notices
WARNING: NEVER operate the ventilator while covered or set up in a way to negatively impact the operation or function. WARNING: Always unplug the ventilator from the power source before opening the housing. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 11 WARNING: DO NOT modify the equipment. WARNING: Before applying non-original accessories, ensure that they are biocompatible. All accessories supplied by ACUTRONIC Medical Systems for use on fabian ventilators are biocompatible. WARNING: When connected to a patient DO NOT simultaneously touch the external power supply cord and the flow sensor connector cable.
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Page 12: Maintenance
Inspection according to manufacturer specifications is required every 12 months. • Maintenance must be performed by ACUTRONIC Medical Systems trained personnel with access to appropriate test and measuring equipment. We strongly recommend ACUTRONIC Medical Systems AG exclusive representatives for service agreements and repairs. -
Page 13: Liability For Functionality ∕ Damages
2.3 Liability for functionality ∕ damages In the event of improper equipment maintenance or repair by any person not associated with ACUTRONIC Medical Systems AG Service or improper use, any and all liability for the functionality is transferred to the owner or operator. -
Page 14: System Overview
Severe airflow obstruction, and intracranial hypertension, would contraindicate the use of the fabian Therapy evolution neonatal and infant ventilator. Fabian Therapy evolution products should not be used in association with HF electrosurgical equipment. In the event of ventilation for several hours or more, care must be taken for optimal conditioning of the respiratory gases (warmth, humidification) to optimize secretion mobilization and prevent damage to mucous membranes. -
Page 15: Rear Panel
Connection for compressed air supply 2.0 – 6.0 bar / max 40 l/min Connector for Masimo SpO module Oxygen sensor access cover Connection for oxygen “O ” supply 2.0 – 6.0 bar / max 40 l/min fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 16: Rear Panel Of Devices Till Sn At 03999
Connection for future use, covered with a faceplate Oxygen sensor Connection for future use, covered with a faceplate Connection for oxygen “O ” supply 2.0 – 6.5 bar / max 40 l/min fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 17: General Hardware Characteristics
Ethernet: N/A (disabled) Flow Sensor: Maximum load is one Flow sensor (Only ACUTRONIC Medical Systems Flow sensors can connect) Max. Voltage: 5 V Max operating current: 300 mA per hotwire -> 600 mA total. Max Voltage: 3.3 V Max operating Current: 200 mA fabian Therapy evolution | SW 5.1.x... -
Page 18: System Functions And Displays
Waves ∕ Loops …switches to wave-/loop display. Home … displays the main screen for selecting the respiration mode. mode fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 19: Rotary Push Knob
4.2 Display concept structure 4.2.1 Display areas The information system features two key display areas: 1. The Touch screen 2. LED indicators fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 20: Display Screen
Alarm Mute (time remaining until alarm reactivates) Time / Date The Patient symbol indicates patient data associated with the current ventilator operation is saved to the device. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 21: Numeric Field / Alarm Limits
To go to the next page, press the button (1) below the numeric field. Depending on the Ventilation mode the data is updated as average/minute or by breath. Numeric field fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 22 WARNING: The respiratory rate and minute volume monitors are calculated as averages using an update period of 6 seconds. In the event that the monitored breath rate falls below 11 bpm, these values are not reported. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 23: Graphic Field
2. Report the incident to your local distributor 3. Do not use the device until it has been checked by suitably trained and qualified personnel. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 24: Ventilation Menu
Ventilation menu indicates the configuration parameters (4) and measurements (5) relevant in the mode. The Information bar (1) indicates current information. The Ventilation parameters can be changed in the menu. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 25: Operation - Settings
List of dependencies: • Flush min. 2 Vol% above O setting, max. 100 Vol% • PDUO min 2 mbar over PEEP • min 2 mbar over CPAP manual fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 26: Locking Ventilator Parameters
Keypad. The Graphics menu Displays the current values in big letters and also shows the pressure wave. Use the Graphics button to access the big screen menu. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 27: Trend Menu
A confirmation message will always be displayed before trend data is deleted. Parameter selection for graphic waves Graphics Parameter values Timeline Adjust timeline (max. 5 days – min. 30 minutes) Update data (refresh) fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 28: System Operation
CGA/ISO standards, including fill indicators. The inputs are coded to prevent wrong connection. Input pressure (2.0 to 6.0 bar) for medical grade Oxygen and Medical grade AIR (dust-free, oil-free and dry). fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 29: Connect Ncpap Tubing
Triggering in DUOPAP mode with flow sensor (optional) Preparing the nCPAP InfantFlow/InfantFlowLP/Inspire Tubing System • Connect Flow sensor to exhalation tube as shown in the picture. Recommendation: • Make the Exhalation tube as short as possible. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 30: System Start-Up
The O will automatically be calibrated after leaving the Calibration menu once every 24 hours. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 31: Device Check
2. Perform the audible alarm test. during switch-ON test. 3. Confirm that the audible tone can be heard Self-test successful. Calibration Calibrate Flow sensor (if available) Calibration successful fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 32: System Standby / Pause
3. Press Standby to switch to standby. When the ventilation has stopped the Information bar will display the following message “Ventilation stopped”. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 33: System Shutdown
Before performing this procedure, ensure that the alternate ventilation method (for example: manual resuscitation) is present, ready and standing by. 1. Remove patient from the ventilator. Press and hold the ON ∕ OFF button (1) for one second. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 34 6. Press the Alarm Silence button to confirm system switch OFF. 7. Hold the button for at least three seconds until the WARNING LED stops. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 35: Configurations Menu
Configurations menu in Therapy WITH flow sensor connector 1. Calibration menu Date / Time 2. Display Tools 3. Ventilation Information 4. Patient Data PDMS (optional) 5. Language 10. Service Mode fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 36 Configurations menu in Therapy WITHOUT flow sensor connector 1. Calibration O Tools 2. Display Information 3. Ventilation PDMS (optional) 4. Patient Data 10. SpO sensor 5. Language 11. Service Mode 6. Date / Time fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 37: Calibration
Calibration Menu at Therapy (only with flow sensor connector) From the Calibration screen, you can calibrate the following Sensors: • Flow sensor • sensor • module fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 38: Flow Sensor
When centered, these lines will turn Green. 4. Following successful Calibration, the Date of the last calibration will be displayed in the corresponding area. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 39: O 2 Sensor
6 seconds. If Flow measurements are not regained consider the following: • Flow Sensor Contamination (single-use sensor recommended) • Rain-out (contact ACUTRONIC Medical Systems sales for recommended Patient Circuits and Humidifier to prevent Rain-out) 6.1.2 Sensor The O... -
Page 40: Spo Module
Automatic Sensor Calibration runs every time the equipment restarts and every 24 hours. The gas concentration to patient is not altered during the calibration procedure. 6.1.3 module Please refer to chapter “SpO module” fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 41: Display
Rotary push knob is pressed. Automatic lock activated / deactivated. Touchscreen automatically locks after a set time. Display Graphs and trends as filled or regular lines. Auto scale ON / OFF fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 42: Touch Screen Settings
The touch screen can also be locked by holding the Rotary push knob for 3 seconds Lock is automatically cancelled in the event of an alarm or by pressing the Rotary push knob. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 43: Trend ∕ Graph Display
∕ ) keys Scaling can be performed manually with the ( on the keypad for the timeline. For Wave height, use the Manual inspiration and Flush keys on the keypad fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 44: Ventilation Parameter Settings
Maximum Inspiration time for Manual breath (2 to 30 seconds). for Manual breath optional: The “Hospital Settings” button is only active if it is enabled Hospital Settings in service mode. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 45: Patient Data
Deleting all stored data from the previous patient For data input just touch the Change data and choose the field for input For capital letters touch Accepting data with “Apply” fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 46: Language
1. Use the Up and Down arrows to set the date and time. 2. After the time or date has been changed, the confirmation check mark changes colors. 3. The new information is applied after confirmation. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 47: Tools
Alarm and System log. Device Information SW and HW Configuration with licenses. Only allowed when patient is NOT connected. 6.8 Information Displays the Information screen (System Information) containing Equipment data. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 48: Service Mode
Manual and is only for trained Service technicians. After using service mode and before connecting fabian to a patient, restart the device. Only allowed when patient is NOT connected. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 49: Alarms
Information bar and a Red bell symbol indicates the alarm cause. Also, an audible alarm will sound which may be silenced for 2 minutes by pressing the Alarm Silence button. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 50: Automatic Alarm Limits
Alarm delay set by the operator in the Ventilation menu, the alarm will be signaled, otherwise it is cleared. • If an Alarm Condition has been detected, a dedicated Alarm Array is written, otherwise it is cleared. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 51: Configurable Alarms
High Pulse Rate alarm: 35 to 235 bpm, off • Low Pulse Rate alarm: off, 30 to 230 bpm • Low Perfusion Index alarm: off, 0.03 to 19% • Low SIQ Alarm: off, 5 to 100%. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 52: Alarm Log
In case alarm list or alarm log files reach their limit (100 /approx.. 70000 entries respectively), the oldest entries are deleted first. 7.3 Nurse call relay The delay from the nurse call relay is < 1 second. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 53: Alarm Causes And Solutions
System error contact your local Acutronic Medical Systems Distributor Disconnect the device from AC power and parallel System failure System error contact your local interface Acutronic Medical Systems Distributor fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 54 System failure System error monitoring Acutronic Medical Systems Distributor • Change battery, No power or too few Battery defect Electrical power • Check fuse. power from battery. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 55 Oxygen sensor sensor defective. Replace O sensor. Sensor alarms defect Replace O sensor as Oxygen sensor quickly as possible. sensor worn. Sensor alarms used up Calibration still available. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 56 15 • Check tubing. seconds. • Adjust settings • Check patient, • Check SpO measured sensor High SpO Patient alarms above set limit for correct contact with patient fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 57 The device • Remaining battery continues in battery time < 30 min. mode without interruption. • Check patient, High breath Hyperventilation Patient alarms • Adjust frequency rate self-trigger fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 58: Pressure Release Behaviour
If the device software encounters an unexpected ERROR, a window appears in the middle of the screen with the following text in English: “Application fabian.exe encountered a serious Error and must shut down.” fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 59 Prepare an alternative treatment for the patient while the device is kept under supervision Start ventilation of patient with an alternative ventilation method Shut down the device. Report the incident to your local distributor Use the device only if it is unavoidable fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 60: Watchdog Alarms
Use the device only if it is unavoidable In case a WDST 4/16/32/64 error is resolved (only a temporary error) WDST#8 will be triggered and displayed and the device can continue to be used. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 61: Battery Operation
Additional messages will be triggered at a remaining Run Time of: • 15 minutes • 30 minutes • 60 minutes, only if the remaining run time is less than 60 minutes during a Power Failure fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 62 Primary Power Source. After 60 seconds, the Battery is drained, and fabian will power OFF. Depleted Battery – Connect to Main – – Charge battery for approx. 5 hours – fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 63: Operating On External Power Source
External power connection on the back panel. 1/2 minus 3/4 plus • NO charging when connected to 12VDC external power supply • NO monitoring of remaining time on external power supply fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 64: Ventilation Parameters
Maximum duration allowed for manual breaths. Adjustable from 2 – 30s. *In Settings menu • Flush Time All modes Duration of O Flush* Adjustable from OFF; 20 – 120s. *In Settings menu fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 65: Ventilation Modes
Function areas and ventilation parameters. Ventilation additives. If Inspiratory Time is set lower than 1 second; the maximum Pressure can NOT be reached. Depending on the Tubing Set, nCPAP Generator and Humidifier. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 66: O 2 Therapy Mode (High And Low Flow Oxygen Therapy) Hfnc
Flush button in a Ventilation mode to initiate the O Flush. 4. The Flush Concentration can now be set with the Rotary push knob. 5. Pressing the O Flush button again will end the Flush immediately. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 67: Accessories And Options
12.1 Accessories List WARNING: The items shown in this list have been approved for use with fabian Therapy evolution ventilator. Use of non-approved items are NOT recommended and will NOT be recognized or supported by the manufacturer. If a system malfunctions with non-approved parts and ∕... - Page 68 NIV generator – Vyaire InfantFlow LP NIV generator – Medin Medijet InfantFLow, Medijet and InfantFlow LP generators are validated, all other circuits can be used but need to be validated by the user itself. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 69: Spo 2 Module
Here you can find information on the sensor state and software release of the connected module. You can select the sensitivity mode, enable or disable a Fast SAT mode, and set the alarm delay and the SpO averaging time. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 70: Sensitivity Mode
Fast SAT enables rapid tracking of arterial oxygen saturation changes by minimizing the averaging. This mode is clinically applicable during procedures when detecting rapid changes in oxygen saturation is paramount such as induction, intubation, and sleep studies. Fast SAT fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 71: Alarm Delay
There are different averaging times that can be selected (2 to 4, 4 to 6, 8, 10, 12, 14, 16). averaging time fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 72: Prico
USB Type A connector at the opposite end so that it is compatible with the USB device port on the rear panel of the fabian ventilator. The total length of the USB HPLPM, patient cable, and sensor cannot exceed 5 meters. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 73 7-pin LEMO connector at the opposite end so that it is compatible with the 7-pin LEMO device port on the rear panel of the fabian ventilator. The total length of the LEMO HPLPM, patient cable, and sensor cannot exceed 5 meters. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 74: Setting Up Prico
Graphics menu. PRICO will adjust the FiO , to try to keep the SpO within the selected range. PRICO in fabian Therapy evolution & fabian + nCPAP evolution PRICO has the following parameters: PRICO Parameters Min FiO Minimum allowed FiO . -
Page 75: Prico Ventilation Modes
PRICO is available on the fabian ventilators in the following modes: • High and Low Flow Oxygen Therapy HFNC (O Therapy) • NIV Bi-levels positive airway pressure (DUOPAP) • NIV Continuous Positive Airway Pressure NCPAP) fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 76: Prico Disabling Alarms
Clean flow sensor Oxygen sensor used up • • Check SpO sensor Oxygen supply pressure • • Flow sensor defect Patient disconnected • • Flow sensor not connected module disconnected fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 77: Prico Re-Enabling Cases
An alarm condition due to reached alarm limit is displayed with a alarm icon at the corresponding alarm limit and as a flashing text with Yellow background in the Information bar. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 78: External Communication, Pdms
PDMS interface is called acuLink. A license is needed to activate this feature, which can be ordered through your local distributor. fabian supports acuLink with three different protocols: 1. Acutronic proprietary RS232 protocol without wave data 2. Acutronic proprietary RS232 protocol with wave data 3. IVOI protocol from Philips for Intellibridge/Vuelink via RS232 There are two major version of our acuLink protocol available: version 3 and version 4. - Page 79 IHE HL7: IntelliBridge EC40/80 modules protocol HL7: IntelliSpace Critical Care and Anesthesia (ICCA) system • GE Healthcare • Cerner • Dräger • AGFA • Mindray • METAVISION iMDSoft fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 80: Replacing The Oxygen Sensor
When installing a brand new sensor a second calibration can be necessary after about 30 minutes. If possible, expose the new sensor for about 30 minutes to the ambient air BEFORE installing fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 81: Ventilator Service And Maintenance Intervals
• sensor • Flow sensor Maintenance and safety inspections must be performed by ACUTRONIC Medical Systems trained personnel with access to suitable testing and measuring equipment. Maintenance Interval Indicator. The symbol will appear in the Information bar 30 days before the next maintenance has to be performed. -
Page 82: Sterilization ∕ Cleaning ∕ Disinfection
Use more dampened cloths if necessary to keep the surface moist for five minutes. 3. Wipe the enclosure with a clean lint-free cloth dampened with purified water for one minute. 4. Allow to dry in the air. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 83: Accessories
3. Remove any visible soiling on the flow sensor cable with the cleaning agent using a manual disinfection option listed in section 15.2.1.2. 15.2.1.2 Manual disinfection options Option A: CaviWipes Surface Disinfectant Wipes (EPA REG. NO.: 46781-14) fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 84: Flow Sensor
Remove the flow sensor from the flow sensor cable. 15.2.2.2 Preparation for sterilization by automated cleaning Please follow the steps below: 1. Rinse under running tap cold water (<35°C / 95°F) to remove excess soil. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 85 Option C: 1. Set the autoclave with the following parameters: • 4 preconditioning pulses • Steam cycle at 134°C / 273°F for 5 minutes • Dry cycle for 30 minutes fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 86 3. Autoclave the cassette articles using the cycle parameters in Step 1 15.2.2.4 Duration of use The flow sensor must be replaced after 30 sterilization cycles and also in case that any detected defect is affecting the accessory performance. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 87: Setting Ranges And Parameters
I-time [sec] 0.15 E-time [sec] Frequency [1/min] O2 [%] Flush [%] Flush Time [sec] Man Breath Time [sec] Flowmin [l/min] CPAP [mbar] Pmanual [mbar] PDUO [mbar] fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 88: Technical Specifications
Set value ±5 Vol% for >1 minute at setting of 21 Vol% below threshold Value 18 Vol% Breath Frequency Alarm: If alarm limit exceeded Apnea Alarm Alarm: If no breathing activity is recognized fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 89: Measuring
± 1.75% of reading or 0.1 mbar (whichever is greater) For volume measurements: ± 1.75% of reading or 0.1 mL (whichever is greater) For oxygen level measurements: ± 1% absolute fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 90: Dimensions ∕ Weight
Safety Classification (Applied Parts) From SN AT-04000: Type BF Till SN AT-03999: Type B Electrical Safety Classification Class I (mains power) Internally powered (battery power) Sound Pressure Max. 68 dB (A) fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 91: Data Storage
Communication between GUI and Parallel Interface • Relias: realis Check from the SPI • SPI: Communication between GUI and Monitor PIC. • SPICks: SPI Checksum • Voltage: Voltage Error Check from the SPI fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 92: Gas Blender Function
The Proportional Valves, which also act as return valves, prevent the return flow of a gas into the supply line of the other gas. An Oxygen sensor measures the Inspiratory Oxygen Concentration. Internal Gas Blending function of the fabian Therapy evolution Oxygen 2.0 to 6.0 bar Air 2.0 to 6.0 bar... -
Page 93: Acoustic Energy
Delivered Volume (V ) of individual breaths greater than 35% and error of the DELIVERED VOLUME averaged over a one minute interval greater than 25%. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... -
Page 94: Electromagnetic Compatibility Statement
WARNING: Portable medical HF communication devices could impact fabian Therapy evolution. WARNING: NEVER use fabian Therapy evolution directly adjacent to, or stack with other equipments. If unavoidable, be sure to monitor the equipment for proper operation with this set-up. WARNING:... -
Page 95: Device With Sn From At-04000
Guideline and Manufacturer Declaration – Electromagnetic Emissions The device fabian Therapy evolution is intended for operation in the environment described below. The customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment. - Page 96 Guideline and Manufacturer Declaration – Electromagnetic Immunity The device fabian Therapy evolution is intended for operation in the environment described below. The customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.
- Page 97 Guideline and Manufacturer Declaration – Electromagnetic Immunity The device fabian Therapy evolution is intended for operation in the environment described below. The customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.
- Page 98 The operator of the fabian Therapy evolution can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device fabian Therapy evolution – depending on the output rating of the communication device, as listed below.
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Page 99: Device With Sn Till At-04000
Guideline and manufacturer declaration – electromagnetic emission The device "fabian Therapy evolution" is intended for operation in the environment described below. The customer or user of the "fabian Therapy evolution" apparatus should ensure it is operated in this type of environment. - Page 100 (50/60 Hz) typical values in business and IEC 61000-4-8 hospital environments. Remark is the mains alternating voltage prior to applying the test level. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
- Page 101 Guideline and manufacturer declaration – electromagnetic immunity The device fabian Therapy evolution is intended for operation in the environment described below. The customer or user of the fabian Therapy evolution apparatus should ensure it is operated in this type of environment.
- Page 102 HF communication devices and the device " fabian Therapy evolution " fabian Therapy evolution is intended to be operated in an electromagnetic environment with controlled HF interferences. The operator of the fabian Therapy evolution can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the device fabian Therapy evolution –...
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Page 103: Appendix A: Glossary
Non-Volatile Random-Access Memory. Flush Delivers oxygen directly into the common gas outlet without passing through a flowmeter or vaporizer. PACU Post-anesthesia care Unit sometimes referred to as Post-Anesthesia Recovery (PAR). fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 104 Used for testing Ventilator equipment. Trend A general direction in which something is developing or changing. Universal Serial Bus, communication cables and connections. USB HPLPM Link Power Management. Video Graphics Array. fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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Page 105: Appendix B: Index
Inspiratory Oxygen Concentration, 89 MicroPod CO2, 103 Electromagnetic compatibility, 94 module, 37, 69, 73, 76 environments, 10, 96 Monitoring, 88 equipment, 6, 7, 10, 11, 12, 28, 40, 81, 94, 103, 104 fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22... - Page 106 Warning, 10, 11, 12, 28, 33, 34, 61, 94 Ratings, 90 Chemical burn, 7 Dangerous voltage, 7 Fire hazard, 7 warnings, 6 Sensitivity mode, 70 sensor, 39, 40, 65, 89 fabian Therapy evolution | SW 5.1.x Ref: 121003.EN / Date 2020-01-22...
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